Comparing early proton pump inhibitor use to standard care for kidney injury in trauma patients
Official title: Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury (CEPU-AKI) in Hemorrhagic Shock Patients: A Prospective Randomized Controlled Trial
Run by The University of Texas Health Science Center, Houston · NCT06531642 · Data updated 2026-11-12
This study is testing if giving the heartburn medication pantoprazole early can help prevent kidney injury in trauma patients who are in shock.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | September 7, 2024 |
| Main results expected | July 31, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | February 19, 2026 |
| Trial ID | NCT06531642 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old who meet the criteria for hemorrhagic shock due to traumatic acute bleeding.
✕Probably not a fit
Patients under 18 years of age, those on renal replacement therapy, or with a history of PPI sensitivity may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate whether the early initiation of the proton pump inhibitor pantoprazole can reduce the incidence of acute kidney injury (AKI) in trauma patients experiencing hemorrhagic shock. It is a single-center, randomized, controlled trial involving 100 adult patients who will be assigned to receive either early or routine administration of pantoprazole for two days following their injury. The study will assess kidney injury through urinary biomarkers and track the incidence and severity of AKI, as well as major adverse kidney events over a 30-day period. The findings could provide insights into optimizing treatment protocols for trauma patients at risk of kidney damage.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of acute kidney injury in trauma patients, leading to better outcomes and reduced mortality.
How similar studies have gone: While the specific approach of early PPI use in this context may be novel, similar studies have indicated potential benefits of early intervention in reducing organ damage in trauma patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (≥18 years of age) * Patient meets hemorrhagic shock criteria: * Hypovolemic shock from traumatic acute bleeding * Systolic blood pressure ≤ 90 mmHg AND tachycardia (HR ≥ 108) at presentation to the ED; OR * Systolic blood pressure ≤ 70 mmHg at presentation to the ED. Exclusion Criteria: * Patients \<18 years of age * Patients known to be actively on renal replacement therapy * Cardiac arrest prior to ED arrival or who are deemed to have expected survival of less than 24 hours * History of PPI sensitivity or allergy * Patient who are already enrolled in other trials prior to ED arrival and these trials do not allow co-enrollment * Patient who presents with ongoing GI bleeding that will require higher dose of GI prophylaxis * Vulnerable populations such as pregnant women and prisoners
Where it's running
-
Memorial Hermann Texas Medical Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Yafen Liang, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Yafen Liang, MD
- Email: yafen.liang@uth.tmc.edu
- Phone: 713-500-6226
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Remote Ischemic Preconditioning at Different Times After Heart Valve Surgery
This study tests whether applying brief, controlled blood-flow restrictions to a limb at different times after heart valve surgery can help protect organs and reduce complications like kidney injury.
-
Clinical decision support to help consider SGLT2 inhibitors after AKI in type 2 diabetes
This pilot test checks if a CDS message given to clinicians can help decide whether to consider SGLT2 inhibitors for adults with type 2 diabetes who recently had acute kidney injury.
-
Biomarkers to predict CSA-AKI risk before heart surgery
This study tests new biomarkers to see if they can predict CSA-AKI risk in adults undergoing cardiovascular surgery.
-
Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter
This trial tests whether using the oXiris hemofilter during continuous kidney replacement helps lower endotoxin levels in adults with septic shock who need CRRT.
-
Perioperative GFR Monitoring to Predict CSA-AKI and CA-AKI
This study tests whether perioperative transcutaneous fluorescence GFR measurements can predict CSA-AKI or CA-AKI in adults undergoing cardiovascular procedures or iodine contrast exposure.
-
Restarting RAS inhibitors after AKI: a quick test in hospitalized adults
This pilot study tests whether restarting renin-angiotensin system inhibitors early after acute kidney injury is feasible and safe in hospitalized adults already using these medicines.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.